Ignite Creation Date:
2024-05-05 @ 5:29 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00461006
Status:
COMPLETED
Last Update Posted:
2016-08-01
First Post:
2007-04-16
Brief Title:
A Comparison of the Effects of Aleglitazar and Actos on Renal Function on Patients With Type 2 Diabetes
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Randomized Double Blind Study to Compare the Effects of Aleglitazar and Actos on Glomerular Filtration Rate and Other Parameters of Renal Function in Patients With Type 2 Diabetes
Status:
COMPLETED
Status Verified Date:
2016-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This 2 arm study will compare the effects of aleglitazar and Actos added to preexisting oral antihyperglycemic therapy andor diet and exercise on renal function in patients with type 2 diabetes and normal or mildly impaired renal function Eligible patients will be randomized to receive either aleglitazar 06mg po or Actos 45mg po daily Renal function and efficacy parameters will be assessed at intervals during the treatment period The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None